Drug Discovery World

AUGUST 22, 2023

This will continue to be the case going forward, but the nature of the off-patent landscape will evolve in line with ongoing changes in the segment’s ‘pipeline’: the originator products of today, which will become the generic and biosimilar medicines of tomorrow. In all, around 130 clinical trials are ongoing for oligonucleotides.

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Production Pharma Companies Clinical Trials FDA 130

The Pharma Data

OCTOBER 14, 2021

The results, which demonstrate that patients treated with Biogen’s portfolio of MS therapies mount an effective antibody response to COVID-19 vaccination, are being presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) virtual meeting, October 13-15, 2021.

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Vaccine Therapies Immune Response Disease 52

Agency IQ

JULY 26, 2024

FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms Meeting a biosimilar user fee commitment, the FDA is expanding on its recommendations for biosimilar and interchangeable product applicants asking the FDA for post-approval manufacturing changes.

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Biosimilars Science FDA Licensing 40

The Pharma Data

JULY 27, 2021

. “Over the last five years, Teneobio developed leading-edge expertise in efficiently engineering differentiated multispecific and bispecific therapeutics for numerous indications with potentially better safety, efficacy and pharmacokinetic profiles than the first generation of T-cell engagers. ” In June 2021, AbbVie Inc.

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Production Clinical Trials Government Disease 52

The Pharma Data

FEBRUARY 8, 2021

Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1.0% The pharmacokinetics of IBRANCE have not been studied in patients requiring hemodialysis. DISCLOSURE NOTICE : The information contained in this release is as of February 5, 2021. of IBRANCE-treated patients had ILD/pneumonitis of any grade, 0.1%

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Clinical Trials Treatment Therapies Production 52

The Pharma Data

NOVEMBER 6, 2020

With the opinions expressed at the Advisory Committee and the data presented, the FDA will continue the review process with a decision on whether to approve the aducanumab Biologics License Application by March 7, 2021. . About Aducanumab. The safety and tolerability of aducanumab was the primary aim of the study. About Alzheimer’s Disease.

Disease 40

Disease FDA Clinical Trials Licensing 40

Agency IQ

FEBRUARY 15, 2024

We have tried to sort guidance documents by topic area.

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FDA Science Biosimilars Production 40